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Study on the Effectiveness and Safety of Danicopan for Adults with Chronic Spontaneous Urticaria Resistant to H1-Antihistamines

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What is this study about?

This clinical trial is focused on studying a condition known as chronic spontaneous urticaria, which is a type of hives that appears without a known cause and lasts for more than six weeks. The study is testing a new treatment called Danicopan, which is a factor D inhibitor. This means it works by blocking a part of the immune system that might be involved in causing the hives. The trial aims to see if Danicopan can help reduce the symptoms of chronic spontaneous urticaria in adults who have not responded well to standard treatments like H1-antihistamines, which are common allergy medications.

Participants in the study will receive Danicopan in the form of a film-coated tablet taken orally. The study will compare the effects of Danicopan on patients with different levels of a protein in the blood called IgE, which is often linked to allergic reactions. The trial will last for about 17 weeks, during which the changes in the severity of the hives will be monitored. The study will also look at how the treatment affects the quality of life of the participants and their use of other medications for relief.

In addition to Danicopan, participants will need to be vaccinated against Neisseria meningitidis, a type of bacteria that can cause serious infections. This is because the study involves treatments that might affect the immune system. The trial will help researchers understand if Danicopan is a safe and effective option for people with chronic spontaneous urticaria who have not found relief with other treatments.

1 initial assessment

The study begins with an initial assessment to confirm eligibility. This includes verifying a diagnosis of chronic spontaneous urticaria for more than six months and ensuring the condition is moderate to severe and resistant to standard treatments.

Eligibility also requires a complete vaccination against Neisseria meningitidis within the last three years or a willingness to receive the necessary vaccinations or boosters.

2 baseline measurement

The baseline measurement involves recording the Urticaria Activity Score (UAS7), which ranges from 0 to 42, to assess the severity of symptoms. This score is used to track changes throughout the study.

3 treatment phase

The treatment phase lasts for 17 weeks. During this period, the medication Danicopan, a factor D inhibitor, is administered.

Danicopan is provided in two forms: as a solution for injection in a pre-filled syringe and orally. The specific dosage and frequency are determined by the study protocol.

4 monitoring and evaluation

Throughout the treatment phase, regular monitoring is conducted to evaluate the effectiveness and safety of Danicopan. This includes tracking changes in the UAS7 score from the baseline to the end of the treatment phase.

Additional assessments include the Urticaria Control Test (UCT) and Angioedema Activity Score (AAS) to measure disease control, as well as quality of life questionnaires specific to dermatological and chronic urticaria conditions.

5 completion of study

At the end of the 17-week treatment phase, a final evaluation is conducted to determine the overall change in symptoms and quality of life.

The study aims to assess the primary endpoint, which is the change in the UAS7 score from baseline to week 17, and secondary endpoints related to disease control and quality of life.

Who Can Join the Study?

  • Have a diagnosis of chronic spontaneous urticaria for more than 6 months. This is a condition where you have itchy hives that appear without a known cause.
  • Be 18 years of age or older.
  • Have moderate to severe chronic spontaneous urticaria that does not respond to standard treatments. This means you have had itch and hives for at least 6 weeks in a row before joining the study, even while taking H1-antihistamines, which are common allergy medications.
  • Have a Urticaria Activity Score (UAS7) of 16 or higher in the week before starting the study. This score measures the severity of your urticaria symptoms over a week, with a range from 0 to 42.
  • Be fully vaccinated against Neisseria meningitidis within the last 3 years, or be willing to receive the necessary vaccinations or boosters. This is a type of bacteria that can cause serious infections.

Who Cannot Join the Study?

  • Patients who have a history of severe allergic reactions to the study medication or its ingredients.
  • Patients who are currently participating in another clinical trial.
  • Patients with other significant health conditions that could interfere with the study.
  • Patients who are pregnant or breastfeeding.
  • Patients who have used certain medications that might affect the study results.
  • Patients with a history of drug or alcohol abuse.
  • Patients who have had a recent major surgery.
  • Patients with unstable mental health conditions.
  • Patients who are unable to comply with the study procedures.
  • Patients with a known infection that could affect the study.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Center For Pediatric And Adolescent Medicine Of The Johannes Gutenberg University Mainz Mainz Germany

Other Sites

Site Name City Country Status
Charite Universitaetsmedizin Berlin KöR Berlin Germany
Philipps-Universitaet Marburg Marburg Germany
Uklgicdxjeqxynczasdux Mmrxjfco Akr Munster Germany

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Germany Germany
Not recruiting
01.11.2024

Trial locations

Investigated drugs:

Danicopan is a medication being studied for its potential to help patients with chronic spontaneous urticaria, a condition characterized by persistent hives. It works by inhibiting Factor D, a part of the immune system that may play a role in the development of these hives. The trial aims to see if Danicopan can reduce the severity of symptoms in patients who have not responded well to standard antihistamine treatments.

Investigated diseases:

Chronic Spontaneous Urticaria – This is a skin condition characterized by the sudden appearance of itchy hives or welts on the skin, which can occur without an obvious trigger. The hives can vary in size and may appear and disappear over the course of several hours. In some cases, swelling known as angioedema can also occur, particularly around the eyes, lips, and sometimes the throat. The condition is considered chronic when it persists for six weeks or longer. The exact cause is often unknown, but it may involve the immune system reacting inappropriately. Symptoms can fluctuate in intensity and frequency, making the condition unpredictable.

Trial ID:
2024-512386-14-00
Protocol code:
TMP-08012024-3
Trial Phase:
Therapeutic exploratory (Phase II)

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